Efficacy of an Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis
- Conditions
- Base-of-thumb Osteoarthritis
- Interventions
- Drug: saline
- Registration Number
- NCT03187626
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
The primary purpose of this study is to determine whether a single ultrasound-guided intra-articular injection of botulinum toxin A associated to splinting is effective in reducing pain at 3 months in base-of-thumb osteoarthritis.
- Detailed Description
Base-of-thumb osteoarthritis is a common condition affecting middle-age persons. Base-of-thumb osteoarthritis induces pain and hand-specific limitations in activities. For short and midterm effects, therapeutic options usually include splinting, exercise therapy and intra-articular injections of glucocorticoids or hyaluronic acid. However, evidence of efficacy of intra-articular therapies in base-of-thumb osteoarthritis and international guidelines are inconsistent. Recently, the use of intra-articular botulinum toxin A as a pain killer has raised intense interest. The exact mechanisms of pain modulation by botulinum toxin A in osteoarthritis are unclear. It has been suggested that botulinum toxin A could directly reduce peripheral sensitization and indirectly reduce central sensitization. Indeed, recent studies suggest an inhibitory role of botulinum toxin A on the release of mediators involved in nociception, such as P substance, calcitonin gene-related peptide and glutamate. Open and randomized controlled trials of botulinum toxin A in knee osteoarthritis support short to mid-term positive clinical effects on pain. However, no study has reported results for base-of-thumb osteoarthritis
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Age ≥ 18 years old
- Pain intensity on a self-administered 11-point pain numeric rating scale ≥ 30
- Pain involving the base-of-thumb
- X-ray evidence of base-of-thumb osteoarthritis with at least 2 of the 4 following items involving the trapeziometacarpal joint : osteophytes, joint space narrowing, subchondral bone sclerosis or subchondral cysts
- 1990 American College of Rheumatology classification criteria for hand osteoarthritis adapted to base-of-thumb osteoarthritis
- Medical examination
- Written consent
- Health insurance
- For women of childbearing age, a negative urinary pregnancy test
- History of thumb surgery
- History of inflammatory or crystal-associated rheumatic disease
- Neurological disorders involving the hands other than carpien canal syndrom
- Collagen disorders involving the hands : Dupuytren, Marfan or Ehlers-Danlos diseases
- Osteoarthritis predominating at the scaphotrapezial joint on X-Ray
- Hand or wrist trauma ≤ 2 months
- Hand or wrist intra-articular injections ≤ 2 months
- Contra-indication to botulinum toxin A injection or to splinting
- Cognitive or behavioral disorders making the assessment impossible
- Participant unable to speak, read and write french
- Bilateral BTOA without predominant symptomatic side
- Pregnancy and breast feeding
- Persons referred to in Articles L 1121-5; 6; 8; 9 of the Public Health Code (protected minors or adults, guardianship or trusteeship, etc.)
- Patient with epilepsy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intra-articular saline and splinting saline Ultrasound-guided injection of 1 ml of saline in the trapeziometacarpal joint and custom-made thermoformed plastic splint to be worn for 48 hours after intra-articular injection then nightly Intra-articular botulinum toxin A and splinting botulinum toxin A Ultrasound-guided injection of 50 Allergan Unities of botulinum toxin A (Botox®, Allergan) resuspended in 1 ml of saline in the trapeziometacarpal joint and custom-made thermoformed plastic splint to be worn for 48 hours after intra-articular injection then nightly
- Primary Outcome Measures
Name Time Method Change in base-of-thumb pain 3 months post-injection 3 months post injection Mean change from baseline in average base-of-thumb pain intensity in the previous 48 hrs on a self-administered 11-point pain numeric rating scale (0 no pain - 100 maximal pain)
- Secondary Outcome Measures
Name Time Method Change in patient's global assessment 3 months post-injection 3 months post-injection Mean change from baseline in patient's global assessment on a self-administered 11-point numeric rating scale (0 worst possible - 100 best possible)
Percentage of OARSI responders 3 months post-injection 3 months post-injection OARSI response is defined as an improvement in pain (0 to 100 numeric rating scale) or in function (0 to 90 Cochin Hand Function Scale) ≥ 50% and absolute change ≥ 20/100 on pain numeric rating scale or ≥ 9/90 on Cochin Hand Function Scale respectively , or improvement in at least 2 of the 3 following items: 1/ pain ≥ 20% and absolute change ≥ 10/100, 2/ function ≥ 20% and absolute change ≥ 9/90, 3/ patient's global assessment (0 to 100 numeric rating scale) ≥ 20% and absolute change ≥ 10/100
Change in base-of-thumb pain 6 months post-injection 6 months post injection Mean change from baseline in average base-of-thumb pain intensity in the previous 48 hrs on a self-administered 11-point pain numeric rating scale (0 no pain - 100 maximal pain)
Percentage of OARSI responders 6 months post-injection 6 months post-injection OARSI response is defined as an improvement in pain (0 to 100 numeric rating scale) or in function (0 to 90 Cochin Hand Function Scale) ≥ 50% and absolute change ≥ 20/100 on pain numeric rating scale or ≥ 9/90 on Cochin Hand Function Scale respectively , or improvement in at least 2 of the 3 following items: 1/ pain ≥ 20% and absolute change ≥ 10/100, 2/ function ≥ 20% and absolute change ≥ 9/90, 3/ patient's global assessment (0 to 100 numeric rating scale) ≥ 20% and absolute change ≥ 10/100
Non-steroidal anti-inflammatory drugs consumption at 3 months from injection to 3 months post-injection Self-reported consumption of non-steroidal anti-inflammatory drugs using a self-administered 4-class scale (never; several times a month; several times a week; daily)
Non-steroidal anti-inflammatory drugs consumption at 6 months from 3 to 6 months post-injection Self-reported consumption of non-steroidal anti-inflammatory drugs using a self-administered 4-class scale (never; several times a month; several times a week; daily)
Change in base-of-thumb pain 1 month post-injection 1 month post injection Mean change from baseline in average base-of-thumb pain intensity in the previous 48 hrs on a self-administered 11-point pain numeric rating scale (0 no pain - 100 maximal pain)
Change in hand function 3 months post-injection 3 months post injection Mean change from baseline in average hand-specific limitations in activities in the previous 2 weeks on the self-administered Cochin Hand Function Scale (0 no limitations - 90 maximal limitations)
Change in hand function 6 months post-injection 6 months post injection Mean change from baseline in average hand-specific limitations in activities in the previous 2 weeks on the self-administered Cochin Hand Function Scale (0 no limitations - 90 maximal limitations)
Change in patient's global assessment 6 months post-injection 6 months post-injection Mean change from baseline in patient's global assessment on a self-administered 11-point numeric rating scale (0 worst possible - 100 best possible)
Analgesics consumption at 6 months from 3 to 6 months post-injection Self-reported consumption of analgesics (non-opioid, weak and strong opioids) using a self-administered 4-class scale (never; several times a month; several times a week; daily)
Analgesics consumption at 3 months from injection to 3 months post-injection Self-reported consumption of analgesics (non-opioid, weak and strong opioids) using a self-administered 4-class scale (never; several times a month; several times a week; daily)
Trial Locations
- Locations (1)
Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin
🇫🇷Paris, France